PART IVIn Vitro Diagnostic Medical Devices
F1Register of approved coronavirus test devices38C
1
The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.
2
The Secretary of State must publish the register on the gov.uk website.
3
The register must contain the following information in respect of each coronavirus test device—
a
the name and address of the registered place of business of the person who made the application under regulation 38A;
b
if the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;
c
the country in which the manufacturer is established;
d
the name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;
e
the name and description of the coronavirus test device;
f
the date and version number of the instructions for use included in the application;
g
whether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;
h
the date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.
4
The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.